by Texas Senator Bob Hall
Serving the counties of District 2: Fannin, Delta, Hunt, Hopkins, Rains, Rockwall, Kaufman, Van Zandt, and part of Dallas County
Patients Rights
Informed consent is a vital part of the Texas Health Code
When a loved one is admitted to the hospital, it is easy to let the doctors and nurses follow their training and use their extensive experience to help the patient recover from COVID-19.
Today, however, hospital policies often get in the way of doctor-prescribed treatment plans. The Centers for Medicare and Medicaid Services have created a new enhanced payment opportunity for hospitals using products that have been either approved under an Emergency Use Authorization (EUA) or are newly approved. Currently, that product list includes the medications Remdesivir and Baricitinib.
Remdesivir received emergency use approval in November 2020, in combination with a drug called Baricitinib, which is labeled for use on patients with rheumatoid arthritis. The FDA requires that a recipient of any medical product authorized under an EUA be informed of the following:
- The FDA has authorized emergency use of the product in a specific age group for a specific illness;
- The existence of significant known and potential benefits and risks associated with use of the product;
- The patient has the option to refuse the EUA product without threat of reprisal; and
- Alternative treatment methods as well as possible side effects of those methods.
The FDA recommends the provision of a fact sheet that includes the product name, intended use, description of the illness, contact information for reporting adverse reactions, and dosing information in order to obtain the informed consent of the patient. However, this recommendation is not, as of 2022, codified into state or federal law. No products approved under an EUA may be mandated by state or federal laws.
Informed consent is a vital part of the Texas Health Code. The provision of any medication or procedure without explicit consent by the patient or the person with decision-making power is illegal and potential grounds for a healthcare liability claim under the Civil Practice and Remedies Code, Title 4, Chapter 74.101.
Nurses or doctors may inform you that you will receive a certain medication. You have the right to refuse and request a different treatment. Your doctor works for you, so do not be afraid to tell them what treatment you prefer. Hospital policies may dictate that Remdesivir is the preferred treatment for COVID-19, but studies in France have shown multiple deaths due to renal failure or multiple-organ failure as a result of taking the drug. If that concerns you, ask your doctor if he or she is aware of these studies showing negative outcomes.
Currently, Remdesivir and Baricitinib is a preferred treatment combination for COVID-19. Remdesivir is FDA approved under an Emergency Use Authorization for minors under 12 years old. The antiviral medication is fully approved by the FDA for those over 12 and weighing over 88 lbs. Despite multiple studies indicating that the use of Remdesivir can lead to renal damage and often results in multiple-organ failure, the United States government has decided that it is appropriate for use and provides financial incentives for hospitals to do so.
Hospital systems across Texas have decided to prioritize the use of Remdesivir over other highly successful medications that are used off-label, such as Ivermectin, Hydrochloroquine, and Budesonide. All three of these medications are FDA approved and have been highly successful in treating COVID-19 when administered with a combination of medications in the early days of illness with a significant viral load. However, since they are not labeled or directly approved by the FDA for COVID-19 treatment, some hospitals and doctors will refuse to prescribe or use Ivermectin, Hydrochloroquine, or Budesonide in a hospital setting. This is where you, as the patient, must advocate for yourself. Families have sued and defeated hospitals in court to obtain their preferred courses of treatment for COVID-19.
You also have the right to leave the hospital at any time to receive in-home treatment from a frontline doctor or your choice of provider. No hospital can hold anyone against his will.